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Extensive Circumferential Partial Thickness Sclerectomy in Nanophthalmic Eyes

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ClinicalTrials.gov Identifier: NCT03748732
Recruitment Status : Active, not recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmad Mansour, MD, Clinical Professor, AUB, Rafic Hariri University Hospital

Brief Summary:

Purpose: To describe an extensive scleral excision technique to treat or prevent uveal effusion in nanophthalmic eyes.

Design: Prospective interventional case series.

Methods:

  • Setting: Institutional.
  • Patient Population: Consecutive patients with nanophthalmos were operated on by one surgeon.
  • Intervention Procedure: A single, 90% thickness scleral window extending from immediately behind the extraocular muscle insertions to the vortex veins was performed for 3 and 1/4 quadrants as a circumferential strip.
  • Main Outcome Measure: Resolution or prevention of uveal effusion.

Condition or disease Intervention/treatment Phase
Nanophthalmos Procedure: sclerectomy Not Applicable

Detailed Description:
Surgical Technique All surgeries were performed under general anesthesia by one surgeon (AMM). Because the majority of the patients were young with narrow palpebral fissures and very deep set globes in small orbits, special surgical techniques were required. Lateral canthotomy was performed on all patients except for the first. Limbal 360o conjunctival peritomy was followed by securing of each rectus muscles with a modified muscle hook and 2-0 silk suture. Scleral dissection was performed from immediately behind to the muscle insertions posterior to the vortex veins. A 90% depth scleral window was excised over 3 and ¼ quadrants, excluding 3/4 of the superior temporal quadrant to avoid damaging the superior oblique muscle.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: surgery
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extensive Circumferential Partial Thickness Sclerectomy in Nanophthalmic Eyes
Actual Study Start Date : January 1, 2011
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020



Intervention Details:
  • Procedure: sclerectomy
    scleral flap
    Other Name: maximal scleral excision


Primary Outcome Measures :
  1. resolution of uveal effusion [ Time Frame: 1 month ]
    disappearence of uveal effusion by OCT



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: nanophthalmos -

Exclusion Criteria: None

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748732


Locations
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Lebanon
Rafic Hariri University Hospital
Beirut, South Beirut, Lebanon, 1136044
Sponsors and Collaborators
Rafic Hariri University Hospital
Investigators
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Study Chair: Ahmad Mansour, MD Rafic Hariri University Hospital

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ahmad Mansour, MD, Clinical Professor, AUB, Professor, Rafic Hariri University Hospital
ClinicalTrials.gov Identifier: NCT03748732     History of Changes
Other Study ID Numbers: RaficHaririUHAMM
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: if part of collaboration, we will share the data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmad Mansour, MD, Clinical Professor, AUB, Rafic Hariri University Hospital:
uveal effusion
Additional relevant MeSH terms:
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Microphthalmos
Eye Abnormalities
Eye Diseases
Congenital Abnormalities